Esogasec

Patient Information Leaflet: Patient Information

Esogasec 20 mg, gastro-resistant hard capsules

Esogasec 40 mg, gastro-resistant hard capsules

Esomeprazole

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Esogasec is and what it is used for
• 2. What you need to know before you take Esogasec
• 3. How to take Esogasec
• 4. Possible side effects
• 5. How to store Esogasec
• 6. Contents of the pack and other information

1. What Esogasec is and what it is used for

Esogasec contains the active substance esomeprazole. It belongs to a group of medicines called proton pump inhibitors. These work by reducing the amount of acid produced by the stomach.

Esogasec is used to treat the following conditions:

Adults

• Gastroesophageal reflux disease (GERD): This is where acid from the stomach escapes into the gullet (the tube which carries food from the mouth to the stomach) causing pain and inflammation.
• Stomach ulcers caused by a bacterium called Helicobacter pylori. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Esogasec can also be used to prevent stomach ulcers from forming when you are taking NSAIDs.
• Too much acid in the stomach caused by a growth on the stomach (Zollinger-Ellison syndrome).
• Prevention of rebleeding following treatment of bleeding ulcers with esomeprazole given by injection.

Adolescents from 12 years of age

• Gastroesophageal reflux disease (GERD): This is where acid from the stomach escapes into the gullet (the tube which carries food from the mouth to the stomach) causing pain and inflammation.
• Stomach ulcers caused by a bacterium called Helicobacter pylori. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before you take Esogasec

Do not take Esogasec

• If you are allergic to esomeprazole or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other proton pump inhibitor medicines (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medicine containing nelfinavir (used to treat HIV infection).

If any of the above apply to you, do not take this medicine and talk to your doctor or pharmacist.

Warnings and precautions

Before taking Esogasec, tell your doctor or pharmacist if:

• You have severe liver problems.
• You have severe kidney problems.
• You have ever had a skin reaction after treatment with a medicine similar to Esogasec that reduces stomach acid.
• You are due to have a specific blood test (Chromogranin A).

Taking Esogasec may hide the symptoms of other diseases. Therefore, if you are taking this medicine on a long-term basis, your doctor will want to monitor you (particularly if you are taking it for more than a year). If you notice any of the following serious side effects, you should contact your doctor immediately:

• Sudden onset of severe rash, blistering or peeling of the skin and/or mucous membranes and/or hair loss.
• Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms and acute generalized exanthematous pustulosis.

Esogasec may influence the results of certain laboratory tests (e.g. chromogranin A and gastrin levels). If you are taking this medicine on a long-term basis, your doctor will want to monitor you.

Children under 12 years

Esogasec is not recommended for children under 12 years.

Other medicines and Esogasec

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription. This is because Esogasec may affect how these medicines work, or these medicines may affect how Esogasec works.

Do not take Esogasec if you are taking a medicine containing nelfinavir (used to treat HIV infection).

Tell your doctor or pharmacist if you are taking:

• Atazanavir or saquinavir (used to treat HIV infection).
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazole or voriconazole (used to treat fungal infections).
• Erlotinib (used to treat cancer).
• Citalopram, imipramine or clomipramine (used to treat depression).
• Diazepam (used to treat anxiety, insomnia or epilepsy).
• Phenytoin (used to treat epilepsy). If you are taking phenytoin, your doctor will need to monitor you to check that you are getting the right dose of phenytoin.
• Medicines used to thin the blood, such as warfarin. Your doctor may need to monitor you to check that you are getting the right dose of these medicines.
• Cilostazol (used to treat intermittent claudication – a condition where the legs do not get enough blood).
• Cisapride (used to treat indigestion and heartburn).
• Digoxin (used to treat heart problems).
• Methotrexate (used to treat cancer or rheumatoid arthritis). If you are taking methotrexate, your doctor will need to monitor you to check that you are getting the right dose of methotrexate.
• Tacrolimus (used to prevent the rejection of transplanted organs).
• Rifampicin (used to treat tuberculosis).
• St John’s Wort (Hypericum perforatum) (used to treat mild depression).

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin in combination with Esogasec to treat ulcers caused by a bacterium called Helicobacter pylori, it is very important that you tell your doctor about any other medicines you are taking.

Esogasec with food and drink

The capsules can be taken with or without food.

Pregnancy and breast-feeding

Do not take Esogasec if you are pregnant or breast-feeding unless your doctor tells you to. If you become pregnant while taking Esogasec, consult your doctor right away.

Driving and using machines

Esogasec is not likely to affect your ability to drive or use machines. However, dizziness and blurred vision have been reported. If you experience any of these side effects, you should not drive or use machines.

Esogasec contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

3. How to take Esogasec

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• If you are taking this medicine for a long time (particularly more than a year), your doctor will want to keep a regular check on you.
• If you are taking this medicine as and when you need it, and you get symptoms that you think may be due to the medicine, speak with your doctor.

Dose

• Your doctor will tell you how many capsules to take and when to take them. This will depend on your condition, your age and your kidney function.
• The recommended doses are described below.

Adults aged 18 years and above

Treatment of gastroesophageal reflux disease (GERD):

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is one 40 mg capsule per day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your gullet has not yet healed.
• The recommended dose is one 20 mg capsule per day for 4-8 weeks.

Prevention of relapse of ulcers caused by a bacterium called Helicobacter pylori:

• The recommended dose is one 20 mg capsule per day for 4 weeks.

Prevention of stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs):

• The recommended dose is one 20 mg capsule per day.

Treatment of too much acid in the stomach caused by a growth on the stomach (Zollinger-Ellison syndrome):

• The recommended dose is one 40 mg capsule twice per day.

Prevention of rebleeding following treatment of bleeding ulcers with esomeprazole given by injection:

• The recommended dose is one 40 mg capsule per day for 4 weeks.

Adolescents from 12 years of age

Treatment of gastroesophageal reflux disease (GERD):

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is one 40 mg capsule per day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your gullet has not yet healed.
• The recommended dose is one 20 mg capsule per day.

Prevention of relapse of ulcers caused by a bacterium called Helicobacter pylori:

• The recommended dose is one 20 mg capsule per day for 4 weeks.

How to take the capsules

• The capsules can be taken at any time of the day.
• The capsules can be taken with or without food.
• Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules.

What to do if you have difficulty swallowing the capsules

If you have difficulty swallowing the capsules, you can open them and mix the pellets with half a glass of non-carbonated water, or with a acidic liquid such as apple, orange or grapefruit juice. You can also mix the pellets with a small amount of soft food like yoghurt or applesauce.

Always stir the mixture just before drinking it (the mixture will not be clear). The pellets must not be chewed or crushed.

Children under 12 years

Esogasec is not recommended for children under 12 years.

Elderly

No dose adjustment is necessary for patients over 65 years.

If you take more Esogasec than you should

If you have taken more Esogasec than you should, talk to your doctor or pharmacist straight away.

If you forget to take Esogasec

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue as usual. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Esogasec and see a doctor immediately if you notice any of the following serious side effects – you may need urgent medical attention:

• Sudden onset of severe rash, blistering or peeling of the skin and/or mucous membranes and/or hair loss. This could be erythema multiforme, Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms and acute generalized exanthematous pustulosis.

Other side effects include:

Common (may affect up to 1 in 10 people)

• Headache.
• Diarrhoea, stomach pain, constipation, wind, nausea/vomiting.
• Feeling tired.
• Dizziness, spinning sensation, movement problems, pins and needles, fits.

Uncommon (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Disturbances in liver function test (seen in blood tests).
• Itching, rash, urticaria.
• Fracture of the hip, wrist or spine (if Esogasec is used in high doses and over long duration).

Rare (may affect up to 1 in 1,000 people)

• Blood problems, such as a reduced number of white cells or platelets. This can cause weakness, bruising or make infections more likely.
• Low levels of sodium in the blood. This can cause weakness, tiredness, headache, confusion, muscle cramps, fits or coma.
• Feeling agitated, confused or depressed.
• Taste changes.
• Eyesight problems, such as blurred vision.
• Sudden onset of severe rash, blistering or peeling of the skin and/or mucous membranes and/or hair loss. This could be erythema multiforme, Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms and acute generalized exanthematous pustulosis.

Very rare (may affect up to 1 in 10,000 people)

• Changes in blood count, including agranulocytosis (severe reduction in white blood cell count).
• Aggression.
• Seeing, hearing or feeling things that are not there (hallucinations).

Not known (cannot be estimated from the available data)

Esogasec may in very rare cases affect the white blood cell count, which may lead to increased risk of infection. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems, seek medical attention. You should also inform your doctor about your medicine.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the website of your country.

5. How to store Esogasec

• Keep this medicine out of the sight and reach of children.
• Do not store above 25°C.
• Store in the original package (blisters) or keep the bottle tightly closed in order to protect from moisture.
• Do not use this medicine after the expiry date which is stated on the carton and blister/bottle after EXP. The expiry date refers to the last day of that month.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Esogasec contains

• The active substance is esomeprazole. Esogasec gastro-resistant hard capsules are available in two strengths containing 20 mg or 40 mg of esomeprazole (as esomeprazole magnesium dihydrate).
• The other ingredients are:

Contents of the capsule
Core:carrageenan; cellulose microcrystalline; mannitol; sodium hydroxide; sodium carbonate
Enteric coating:hypromellose; methacrylic acid - ethyl acrylate copolymer (1:1); triethyl citrate; talc; titanium dioxide (E 171); colloidal anhydrous silica
Cap and body of the capsule:
Esogasec, 20 mg, gastro-resistant hard capsules:
Cap:gelatin; titanium dioxide (E 171); yellow iron oxide (E 172); purified water
Body:gelatin; titanium dioxide (E 171); purified water
Esogasec 40 mg, gastro-resistant hard capsules:
Cap:gelatin; red iron oxide (E 172); titanium dioxide (E 171); yellow iron oxide (E 172); purified water
Body:gelatin; titanium dioxide (E 171); purified water

What Esogasec looks like and contents of the pack

Esogasec, 20 mg, gastro-resistant hard capsules:
Gastro-resistant hard capsules: (size 3) white, opaque body and light yellow, opaque cap containing white or almost white enteric-coated pellets.
Esogasec, 40 mg, gastro-resistant hard capsules:
Gastro-resistant hard capsules: (size 1) white, opaque body and orange, opaque cap containing white or almost white enteric-coated pellets.
The capsules are packaged in a high-density polyethylene bottle with a polypropylene screw cap containing a desiccant capsule, or in blisters consisting of a polyamide/PVC/Aluminium/PVC foil.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany

Manufacturer

Medinsa (Laboratorios Medicamentos Internacionales S.A.)
c/ Solana, 26
28850 Torrejón de Ardoz (Madrid)
Spain

This medicinal product is authorised in the Member States of the EEA under the following names:

Germany
Esogasec 20mg/40 mg magensaftresistente Hartkapseln
Spain
Esomeprazol Aristo 20 mg/40 mg cápsulas gastrorresistentes
France
ESOMEPRAZOLE EVOLUGEN PHARMA 20 mg/40 mg gélule gastro-résistante
Poland
Esogasec
Portugal
Esomeprazol Aristo 20 mg/40 mg cápsulas duras gastro-resistentes
Sweden
Esomeprazol NET 20 mg enterokapslar hard

Date of revision of the text:October 2023